A cross-sectional clinical validation study to test and compare the accuracy of iOsteoporos Screen (an intelligent Osteoporosis Screening Solutions System), a fully automated AI enabled digital health tech solutions tool for screening Osteoporosis & Osteopenia and its associated high future risk for fracture at hip and spine using a conventional chest X-ray, acquired during a general health checkup in post-menopausal women and geriatric patients with BMD DXA Scans of bilateral hips and spine and the calculated future risks for fractures using the online FRAX Tool for the Indian population as the standards respectively
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- i).The accuracy of iOsteoporos Screen (an intelligent Osteoporosis Screening Software Solutions
研究概览
简要总结
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“iOsteoporos Screen†is a newly developed novel Artificial Intelligence (AI) enabled Screening Software Solutions Tool that assess the conventional chest X-ray Image (in DICOM/ JEPG format) of a patient and gives a prediction of whether the patient is osteoporotic or normal. Also, it predicts high risk for future fracture with high accuracy. It gives an automated computerized patient’s test report and it can be used as a Clinical Decision Support System to doctors.
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It is an Observational Study to validate the AI-enhanced Software Tool referred above. Also, it is a non-invasive studyand there is no intervention involved in this study.
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We have obtained Institutional Ethical Committee Approvalfor this study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 45.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •i).Post-menopausal Women ii).Geriatric patients of both female and male iii).Known cases of osteoporosis, with and without a previous fracture.
排除标准
- •i).Patient, who will be suffering from the following chronic diseases will be excluded: Thyroid disease (Hypothyroidism and Hyperthyroidism), Cancer, Chronic Liver Diseases, Chronic Kidney Diseases, Chronic Heart Diseases, Organ Transplantation (Kidney, Liver, etc), Severe accident-induced fractures ii).Patient with the following: pacemaker, defibrillator, internal fixations for vertebra and clavicle fracture, bone cement, other foreign metal object iii).Patient with abnormal chest imaging, pneumonia, abnormal lung lesions iv).Patient with artifact in chest X-ray, low-quality image.
结局指标
主要结局
i).The accuracy of iOsteoporos Screen (an intelligent Osteoporosis Screening Software Solutions
时间窗: 3-6 months
Tool) will be evaluated, when compared to BMD by DXA Scans and the computed FRAX Score for the Indian populations as the Standards. Its accuracy would be more than 95%
时间窗: 3-6 months
ii).iOsteoporos Screen Tool can be used as an opportunistic screening tool for Osteoporosis & its risk for fracture at hip and spine using a chest X-ray.
时间窗: 3-6 months
次要结局
- Total number of patients, aged above 45 years(who are in the risk for osteoporosis & its future)
研究者
Dr Shilpa Avarebeel
JSS Medical College & Hospital